NCT07608120

Brief Summary

This randomized controlled trial aims to evaluate the effects of different ratios of electrolyte beverage and water combined with polyethylene glycol (PEG) on bowel preparation quality before colonoscopy. Participants undergoing elective colonoscopy will be randomly assigned to one of three bowel preparation regimens: PEG prepared with water only, PEG prepared with a low ratio of electrolyte beverage and water, or PEG prepared with a medium ratio of electrolyte beverage and water. The primary outcome is adequate bowel preparation assessed by the Boston Bowel Preparation Scale (BBPS). Secondary outcomes include bowel preparation completion rate, tolerability, adverse events, repeat colonoscopy rate, adenoma detection rate, and ingestion rhythm characteristics during bowel preparation. This study also aims to explore whether electrolyte beverage-assisted bowel preparation may improve bowel cleansing quality by influencing participants' ingestion rhythm and adherence during PEG intake.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
405

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
May 2026May 2027

First Submitted

Initial submission to the registry

May 18, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 18, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 27, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

May 27, 2026

Status Verified

May 1, 2026

Enrollment Period

9 months

First QC Date

May 18, 2026

Last Update Submit

May 24, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adequate Bowel Preparation Rate

    Adequate bowel preparation is defined as a total Boston Bowel Preparation Scale (BBPS) score ≥6 with each colonic segment score ≥2 during colonoscopy.

    At the time of colonoscopy on Day 1

Secondary Outcomes (3)

  • Total Boston Bowel Preparation Scale Score

    At the time of colonoscopy on Day 1

  • Bowel Preparation Completion Rate

    During bowel preparation within 1 hour before colonoscopy on Day 1

  • Adverse Event Rate

    During bowel preparation within 1 hour before colonoscopy on Day 1

Study Arms (3)

Water Group

ACTIVE COMPARATOR

Participants receive polyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.

Other: PEG With Water

Low-dose Electrolyte Beverage Group

EXPERIMENTAL

Participants receive polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.

Other: PEG With Low-dose Electrolyte Beverage

Medium-dose Electrolyte Beverage Group

EXPERIMENTAL

Participants receive polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.

Other: PEG With Medium-dose Electrolyte Beverage

Interventions

Polyethylene glycol (PEG) prepared with water only for bowel preparation before colonoscopy.

Water Group

Polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:3 ratio for bowel preparation before colonoscopy.

Low-dose Electrolyte Beverage Group

Polyethylene glycol (PEG) prepared with electrolyte beverage and water at a 1:1 ratio for bowel preparation before colonoscopy.

Medium-dose Electrolyte Beverage Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-75 years scheduled to undergo elective colonoscopy
  • Meet the standard clinical indications for colonoscopy;
  • Able to understand and comply with the bowel preparation procedure and complete oral polyethylene glycol (PEG) intake as required;
  • Able to comply with study-related data collection and follow-up;
  • Provide written informed consent voluntarily.

You may not qualify if:

  • Previously diagnosed colorectal cancer, intestinal obstruction, or suspected intestinal obstruction;
  • Active gastrointestinal bleeding or a definite history of gastrointestinal bleeding within the past 4 weeks (including melena, hematochezia, or hematemesis);
  • Severe renal insufficiency, decompensated heart failure, significant electrolyte imbalance, or other conditions unsuitable for PEG bowel preparation;
  • Known allergy to polyethylene glycol or components of the electrolyte beverage used in the study;
  • Pregnant or breastfeeding women;
  • Any other condition considered by the investigators to make the participant unsuitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2026

First Posted

May 27, 2026

Study Start

May 18, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

May 27, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations